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宁夏回族自治区

4月18日,康华生物(维权)(300841)发布2024年年报,公司全年实现营业收入14.32亿元,扣非净利润4.57亿元。作为A股代表性创新型疫苗企业,康华生物的重组六价诺如病毒疫苗成功实现对外授权(license-out),并有望成为继人二倍体细胞狂犬病疫苗之后公司下一个“王牌产品”。

2024年,受疫苗降价、人口出生率下降等因素影响,疫苗企业业绩面临回调压力。2024年前三季度,A股14家疫苗上市公司中有10家“营利双降”,近期已披露2024年年报的疫苗企业中,主营HPV疫苗、流感疫苗的多家上市公司营收和净利润均大幅下滑。

在此背景下,康华生物业绩基本维持稳定,公司持续推进创新研发,实现技术出海,并在行业调整期进一步深化品牌和渠道建设,以疫苗产品核心竞争优势为出发点,不断提高市场覆盖率并促进渠道下沉。

当前,新型疫苗不断升级迭代,针对未满足需求的重磅疫苗陆续上市,在国产疫苗加速“出海”,创新疫苗国产替代趋势持续演进的背景下,康华生物将聚焦重点研发项目,促进研发成果落地,推动公司未来实现可持续增长。

六价诺如病毒疫苗“出海”商业化进程提速

2024年是康华生物成立20周年,经过长期技术积累的康华生物也在创新型疫苗领域实现重大突破,不仅实现技术出海,也为公司经营开启了新的增长点。

2024年1月,康华生物与国际疫苗企业hillevax签署独家许可协议,授权HilleVax在除中国(含港澳台)以外地区对重组六价诺如病毒疫苗及其衍生物进行开发、生产与商业化,交易金额包括首付款1500万美元,最高2.555亿美元的开发里程碑和销售里程碑款项,以及实际年净销售额个位数百分比的特许权使用费,创下中国疫苗License-out金额之最。

诺如病毒是全球急性胃肠炎的主要病原体,每年导致近7亿人感染、20万人死亡,但至今尚无疫苗上市,传统研发路径因病毒变异快、体外培养难而屡屡受挫。康华生物通过收集流调信息,和公共卫生专家、流行病学专家集中探讨,最终选定了六种诺如病毒主要流行基因型,开发重组六价诺如病毒疫苗,由此也成为在研价次最高的多价诺如病毒疫苗之一。

针对未满足需求的创新疫苗产品,也意味着良好的商业前景。诺如病毒感染性腹泻在全世界范围内均有流行,在国内,据中国国家疾控中心信息,每年10月到次年3月是我国诺如病毒感染高发季节,是导致急性胃肠炎的最常见病原体之一,国内多地也曾发生群体感染事件。据FrostSullivan的数据,随着中国诺如病毒疫苗管线研发进度和临床进度的推进,预计最早2026年将有相关产品获批上市;2026-2031年,中国诺如病毒疫苗市场规模可由15.3亿元增长至229.3亿元,年复合增长率达71.85%。

康华生物年报披露,公司重组六价诺如病毒疫苗在2024年12月取得国内临床试验许可,此外,ACYW135群脑膜炎球菌结合疫苗、人用狂犬病疫苗(人二倍体细胞)固定化生物反应器培养工艺计划在2025年申报临床试验。

对于康华生物而言,无论是为公司持续贡献业绩的人用狂犬病疫苗,还是加速迈向商业化的重组六价诺如病毒疫苗,都是“含金量”极高的大单品,尽管在医药控费等因素影响下疫苗市场存在一定起伏,但随着人口老龄化、公众接种意识提高,相关品种疫苗仍有着很大的渗透空间,这也为康华生物未来持续增长奠定坚实基础。

长期主义凸显增长潜力“耐心资本”增持

疫苗行业呈现研发周期长、资金投入大且生产及质控要求高的特点,使疫苗行业具有较高壁垒,呈现寡头垄断格局。这也决定了疫苗企业唯有坚持长期主义,持续投入研发创新和开拓市场才能获得可持续回报。

长期以来,默沙东、葛兰素史克、辉瑞等国际领先疫苗企业占据全球疫苗市场的大部分份额,如13价肺炎球菌多糖结合疫苗、HPV疫苗等重磅产品上市十余年后,销售额依然位居前列。对于中国本土疫苗企业而言,未来增长空间一方面在于国产替代,以高质量本土产品替代进口疫苗,与此同时,面向发达国家和发展中国家市场的“出海”,也将为本土疫苗企业开拓新空间。

在国产替代方面,2021年出台的《“十四五”国家药品安全及促进高质量发展规划》提出,支持疫苗领域创新发展,推动关键核心技术攻关,促推解决产业创新发展的“卡脖子”问题,部分本土疫苗企业在这方面已有成功案例。值得注意的是,中国人均疫苗发展公共支出相对较低,随着国民健康意识提高,相关研究指出,中国疫苗行业相较发达国家仍有2-8倍增长空间。

在国产疫苗“出海”方面,除向发展中国家输出疫苗外,如康华生物的重组六价诺如病毒疫苗成功实现了向发达国家的技术输出,堪称近年来创新疫苗出海的典型案例。

正是着眼于疫苗市场的广阔市场空间,康华生物已布局mRNA疫苗平台、重组蛋白VLP疫苗平台、多糖蛋白结合疫苗平台、减毒活疫苗平台、灭活疫苗平台、新型疫苗佐剂平台等多个创新疫苗平台,循序渐进推进相关管线的研发和商业化。未来,包括新疫苗品种的推出,以及疫苗产品迭代,都将成为创新疫苗企业的新增长点。

事实上,着眼康华生物的良好发展前景,2024年下半年以来已有多家“耐心资本”加持康华。

年报显示,截止2024年12月31日,相较于上一报告期,新进的流通股东中,四川国资“四川发展证券投资基金管理有限公司-川发精选3号私募证券投资基金”本期持有807.9万股,占流通股比例6.7%。增持的股东中,社保基金422组合本期较上期自持股份增持38.08%至197.04万股。一季报显示,截止2025年3月31日,新进的流通股东中,北向资金本期持有182.7万股,占流通股比例1.52%。

4月18日,康华生物在发布年报及一季报的同时,发布公告称拟将回购账户中的300万股用途由“用于实施员工持股计划或股权激励”,变更为“用于注销并相应减少注册资本”。股份注销通常被视为公司对自身价值的高度认可,有助于提升每股收益(EPS)和股东权益回报率(ROE),亦显示了康华生物对自身长期价值的信心。

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